Salvage Cryotherapy in Recurrent Prostate Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

January 15, 2009

Last Updated Date

June 8, 2009

Start Date ^ICMJE

January 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Biochemical failure after treatment (defined as nadir PSA value + 2 ng/dl documented in the postoperative period). [ Time Frame: 3-6 months intervals during the first 2 years after the completion of the procedure and yearly thereafter unless is amended by the treating physician ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00824928 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Percentage change in QoL scores (EPIC) if available [ Time Frame: 3-6 months intervals during the first 2 years after the completion of the procedure and yearly thereafter unless is amended by the treating physician ] [ Designated as safety issue: No ]
Percentage change in AUA-symptom score (also referred to as IPSS score) [ Time Frame: 3-6 months intervals during the first 2 years after the completion of the procedure and yearly thereafter unless is amended by the treating physician ] [ Designated as safety issue: No ]
Percentage change in erectile dysfunction as measured by Sexual Health Inventory for men score (SHIM also referred to as IIEF score) [ Time Frame: 3-6 months intervals during the first 2 years after the completion of the procedure and yearly thereafter unless is amended by the treating physician ] [ Designated as safety issue: No ]
Percentage change in urinary symptoms (continence score) [ Time Frame: 3-6 months intervals during the first 2 years after the completion of the procedure and yearly thereafter unless is amended by the treating physician ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Salvage Cryotherapy in Recurrent Prostate Cancer

Official Title ^ICMJE

A Prospective Multicenter Registry of Salvage Cryotherapy in Recurrent Prostate Cancer Study

Brief Summary

To provide a systemic, uniform and user-friendly tool for collection of data on prostate cancer salvage cryotherapy in a multicenter setting. The goal is to learn more about the short and long term efficacy and safety of this procedure. Ultimately the data analysis will serve as a robust guidance instrument for improving upon the utilization of this procedure for the treatment of patients with recurrent (LRD) prostate cancer.

Detailed Description

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Case-Only, Prospective

Condition ^ICMJE

Recurrent Prostate Cancer

Intervention ^ICMJE

Procedure: Cryoablation / Cryotherapy

Study Arms / Comparison Groups

Patients with locally recurrent prostate cancer that have chosen salvage cryotherapy

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

800

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Read & understand informed consent related to this study including consenting and HIPPA authorization
Undergone salvage cryotherapy of the prostate for recurrent prostate cancer

Exclusion Criteria:

Patients who underwent radical prostatectomy as their primary therapy or other significant surgery (except prostatic biopsy)
Patients with clinically confirmed distant metastasis (unless deemed beneficial by the treating physician)
Any previous major rectal surgery
Clinically significant lower urinary tract or rectal anomalies
Existing urethral, rectal, or bladder fistulae

Gender

Male

Ages

30 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Al Barqawi, MD

720-848-0922

al.barqawi@ucdenver.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00824928

Responsible Party

Albaha Barqawi, MD, University of Colorado at Denver and Health Sciences Center

Study ID Numbers ^ICMJE

06-1040

Study Sponsor ^ICMJE

University of Colorado at Denver and Health Sciences Center

Collaborators ^ICMJE

Endocare, Inc.

Investigators ^ICMJE

Study Chair:	Al Barqawi, MD	University of Colorado at Denver and Health Sciences Center
Study Chair:	David Crawford, MD	University of Colorado at Denver and Health Sciences Center

Information Provided By

University of Colorado at Denver and Health Sciences Center

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP